Asian Journal of Pharmaceutical Analysis

Pankaj Savani ¹, Sudhanshu Chauhan ¹, Vineet Jain ², Hasumati Raj ¹, Sagar Patel ¹

Affiliations
1 Department of Quality Assurance, Shree Dhanvantary Pharmacy College, Kim, Dist: Surat, Gujarat 394110, IN
2 Department of Pharmacognosy, Shree Dhanvantary Pharmacy College, Kim, Dist: Surat, Gujarat 394110, IN

Abstract

A simple, accurate and precise spectroscopic method was developed for simultaneous estimation of Clopidogrel Bisulphate and Irbesartan in synthetic mixture using simultaneous equation Method. In this spectroscopic method, for Clopidogrel Bisulphate 220.00 nm and 250.00 nm wavelengths were selected for measurement of absorptivity. Both the drugs show linearity in a concentration range of 10-50 μg/ml at their respective λmax with correlation coefficient (r2) of 0.9996 and 0.9998 for Clopidogrel Bisulphate and Irbesartan, respectively. Accuracy, precision and recovery studies were done by QC samples covering lower, medium and high concentrations of the linearity range. The relative standard deviation for accuracy, precision studies were found to be within the acceptance range (< 2%). The limit of determination was 0.243 μg/ml and 0.323 μg/ml for Clopidogrel Bisulphate and Irbesartan, respectively. The limit of quantification was 0.737 μg/ml and 0.980 μg/ml for Clopidogrel Bisulphate and Irbesartan, respectively. Recovery of Clopidogrel Bisulphate and Irbesartan were found to be 99.57 % and 99.68 % respectively confirming the accuracy of the proposed method. % Assay was found to be 99.41 % and 99.22 % for Clopidogrel Bisulphate and Irbesartan, respectively. The proposed method is recommended for routine analysis since they are rapid, simple, accurate and also sensitive and specific by no heating and no organic solvent extraction.

Keywords

Clopidogrel Bisulphate, Irbesartan, Simultaneous Estimation, Validation Method.

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Paras Virani ¹, Rajanit Sojitra ², Hasumati Raj ², Vineet Jain ²

Affiliations
1 Gujarat Technological University, Gujarat, IN
2 Quality Assurance Department, Shree Dhanvantary Pharmacy College, Kim, Surat, IN

Abstract

Atorvastatin is the most efficacious of the currently available HMG-CoA Reductase inhibitors used in antilipidemic and also used in athresclerosis, stroke, cardiac risk. The clinical and pharmaceutical analysis of this drug requires effective analytical procedures for quality control and pharmacodynamic and pharmacokinetic studies as well as stability study. An extensive survey of the literature published in various analytical and pharmaceutical chemistry related journals has been conducted and the instrumental analytical methods which were developed and used for determination as single or combination with other drugs in bulk drugs, formulations and biological fluids have been reviewed. This review covers the most recent many analytical methods including spectrophotometric methods, chromatographic method including HPLC, HPTLC and RP HPLC, liquid chromatography tendam mass spectroscopy were reported.

Keywords

Atorvastatin, Analytical Method, HPLC, Hmg-Coa Reductase Inhibitors, Antilipidemic.

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Paras Virani ¹, Rajanit Sojitra ², Bhadresh Savaj ², Hasumati Raj ², Vineet Jain ²

Affiliations
1 Gujarat Technological University, Gujarat, IN
2 Quality Assurance Department, Shree Dhanvantary Pharmacy College, Kim, Surat, IN

Abstract

A simple, accurate and precise spectroscopic method was developed for simultaneous estimation of Irbesartan and atorvastatin in synthetic mixture using Q absorption Ratio Method. In this spectroscopic method, 234.7 nm (as an isoabsorptive point) and 226 nm wavelengths (λmax of any of the two drugs) were selected for measurement of absorptivity. Both the drugs show linearity in a concentration range of 05-30 μg/ml at their respective λmax and at the isoabsorptive point. Accuracy, precision and recovery studies were done by QC samples covering lower, medium and high concentrations of the linearity range. The relative standard deviation for accuracy, precision studies were found to be within the acceptance range (<2%). The limit of determination was 0.365μg/ml and 0.0622μg/ml for Irbesartan and atorvastatin, respectively. The limit of quantification was 1.108μg/ml and 0.188μg/ml for Irbesartan and atorvastatin, respectively. Recovery of Irbesartan and atorvastatin were found to be 100.51% and 100.16% respectively confirming the accuracy of the proposed method. The proposed method is recommended for routine analysis since they are rapid, simple, accurate and also sensitive and specific by no heating and no organic solvent extraction.

Keywords

Irbesartan, Atorvastatin, Simultaneous Estimation, Q Absorption Ratio Method, Q Value Analysis Method.

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